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Smart Pump Early Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465201
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

Brief Summary:
To demonstrate the safety and feasibility of the Impella® Hemodynamics Platform in measuring and displaying hemodynamic parameters in subjects undergoing High Risk Percutaneous Coronary Intervention (HRPCI)

Condition or disease Intervention/treatment Phase
Cardiac Output Device: Impella CP with Smart Assist (Circulatory Support System) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: An Early Feasibility Study
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: Subjects receiving the Impella/Impella® Hemodynamics platform Device: Impella CP with Smart Assist (Circulatory Support System)
Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission.




Primary Outcome Measures :
  1. The ability to calculate and display cardiac output (CO). [ Time Frame: Through study completion, approximately 2 days ]
    Defined as the number of times a CO calibration sequence is successfully completed and the CO is displayed divided by the number of times the pinging sequence is attempted. The endpoint is a rate and therefore has no units of measure. It is the "number of times CO was successfully completed, and CO is displayed" divided by the "number of times the pinging sequence was attempted"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Subject presents for elective PCI
  3. Subject or the subject's LAR has signed the informed consent
  4. Subject indicated for Impella® support

Exclusion Criteria:

  1. Any contraindication or inability to place an Impella® including tortuous vascular anatomy, femoral bruits or absent pedal pulses
  2. Cardiogenic shock defined as systemic hypotension (SBP<90mmHg or the need for inotropes/vasopressors to maintain an SBP >90mmHg) plus one of the following:

    1. Any requirement for inotropes/vasopressors prior to arrival at the catherization lab
    2. Clinical evidence of end organ hypoperfusion
    3. Use of IABP or any other circulatory support device
  3. Suspected systemic active infection
  4. Suspected or known pregnancy
  5. Known contraindication to heparin, pork, pork products, or contrast media
  6. Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
  7. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary end point.
  8. Subject belongs to a vulnerable population [Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465201


Contacts
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Contact: Samantha Polak, MD., PhD. 978-882-8180 spolak@abiomed.com
Contact: Adam Thompson 208-271-1610 adthompson@abiomed.com

Sponsors and Collaborators
Abiomed Inc.
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Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT04465201    
Other Study ID Numbers: Smart Pump EF Study
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes